An observational study in Tricuspid Regurgitation, sponsored by Edwards Lifesciences. Recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Edwards Lifesciences · Observational
This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Replacement procedure using the EVOQUE system.
This is a retrospective, non-randomized cohort study measuring 2-year effectiveness of the EVOQUE Transcatheter Tricuspid Valve Replacement (TTVR) system in the real-world.
This study will retrospectively evaluate EVOQUE treated patients in the STS/ACC TVT Registry who have at least severe Tricuspid Regurgitation and can be deterministically linked with Medicare data.
This group will be compared to Medicare eligible and EVOQUE eligible patients evaluated in a standard of care setting from a commercial claims database linked with electronic health records.
We will evaluate the primary outcome measure in various subgroups.
There will be continued access enrollment after the primary completion date.
Medicare eligible real-world patients with severe, symptomatic tricuspid regurgitation
Medicare eligible patients who have received an EVOQUE device or are EVOQUE eligible and have at least severe Tricuspid Regurgitation
Exclusion Criteria:
Commercially insured patients who have received an EVOQUE device or are EVOQUE eligible or Medicare eligible patients with less than severe Tricuspid Regurgitation
Medicare patients with at least severe Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Replacement with the EVOQUE device and is identified in the TVT Registry
Other: EVOQUE
Medicare eligible patients with severe, symptomatic Tricuspid Regurgitation that are identifiable in a commercial claims database linked with electronic health records.
This is a retrospective, non-randomized study. The decision to intervene by TTVR with the EVOQUE device is made by the heart team.
Composite (All-Cause Death or Heart Failure Hospitalization)
Time to death or heart failure hospitalization after time zero
Time frame: 2 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Tricuspid Valve Insufficiency→
Edwards Lifesciences